A L-Histidine, monohydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a L-Histidine, monohydrochloride Certificate of Suitability (COS). The purpose of a L-Histidine, monohydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Histidine, monohydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Histidine, monohydrochloride to their clients by showing that a L-Histidine, monohydrochloride CEP has been issued for it. The manufacturer submits a L-Histidine, monohydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Histidine, monohydrochloride CEP holder for the record. Additionally, the data presented in the L-Histidine, monohydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Histidine, monohydrochloride DMF.
A L-Histidine, monohydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Histidine, monohydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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